Dean R Hatt PROVANTIS DISPENSE UNLOCKING THE BOX

Dean R Hatt PROVANTIS DISPENSE – UNLOCKING THE BOX

Opening Thought In a regulated GLP environment, we are sometimes reluctant to change, believing what we have always done, and what we have previously been inspected for, is the safest option This may not, however, be the most efficient or flexible use of resource, so should be look outside the box ? >

Agenda Introduction to Dispense (inside the box) Why look outside the box ? Unlocking the Box Summary

Introduction to Dispense is a single, integrated product designed for the management of test materials, from receipt through the various formulations that take place in the course of a typical study. Batches of test materials and vehicles are logged into the system, with expiry dates, and used in the definition of individual formulations for a study.

Introduction to Dispense System prompts for weights and volumes, and records weights and data in a fully GLP compliant fashion Accountability of test materials is achieved by periodically checking theoretical amounts used against the actual amounts. All test materials, vehicles, formulation and sample containers, and balances are barcoded To ensure correct containers are used To ensure balances are calibrated prior to use

Introduction to Dispense System can be used to prepare liquids, fill capsules and make diets and blends Test materials can be solid, liquids or units It allows direct formulations (weigh test material + add vehicle), but also serial dilutions and premixes It uses displacements to calculate amount/weight of vehicle to add (weigh vehicle) or to record weight of vehicle added (QS to volume)

Introduction to Dispense It has standard (system steps) that are hard coded and require the system to read/check barcodes, request (volumes/weights) and record (weights) It allows user defined steps that provide textual instructions for the user

Dispense Development Milestones Booking in as a vehicle F 5 Key to force a weighing / use a different ‘similar’ batch of test material F 6 Key to record comments against any step Addition of dates for aliquots Link with In life ‘Provantis’ system Link with Quantos automated weighing system Link to stored C of A’s

Why Look outside the Box ? When you first demo Dispense, you want it to replicate what you do in your manual preparation When you use Dispense routinely, and suddenly you have to record manually, you want your manual proformae to replicate Dispense calculations + step-wise process makes sense

Why Look outside the Box ? Dispense data is easily viewable and provides, through a fully GLP compliant audit trail, an accurate record of the formulation process Looking outside the box and recording everything on Dispense, provides a one-shop place to record all formulation data

Unlocking the Box Booking in as a Test Material Restriction: A prepared solution/suspension can only be used on the same ‘formulation set up’ and if prepared by serial dilution, can only be used once. Booking any formulation in as a Test Material can allow it to be used on multiple formulation set ups and studies.

Unlocking the Box Formulation in capsules The system allows a test material to be weighed into a capsule or a liquid formulation to be used, but not to add a formulation to a capsule Simply, a formulation is made on Dispense, booked in as a Test Material, and then used to fill a capsule

Unlocking the Box Customised Labels / Reports As Dispense uses crystal reports, user defined labels and reports can be produced and standard labels and reports, can be modified to suit the individual client. A micro label has been created without barcodes and Dispense-specific information and approx 50% of size, to allow labelling of samples sent to third parties.

Unlocking the Box Packing for Inhalation studies Dispense is designed to prepare a formulation, however, it can be used to record steps of any process Here, the formulation definition is built up around a weigh test material step using user defined steps with the operator recording data using the F 6 key

Unlocking the Box

Unlocking the Box Intra-nasal Device Testing This takes things one step further with no weighings in the definition Here, the formulation definition is built up using just user defined steps with the operator recording data using the F 6 key

Unlocking the Box

Unlocking the Box Excipient as Test Material There are times when an excipient needs to be a test material e. g Methylcellulose, when making 1% (w/v) Methylcellulose, with the water as the vehicle However, it is sometimes easier to add an excipient e. g Tween 80, to a final formulation, as a test material

Unlocking the Box Addition of Vehicle to Pre-weighed Drug Here, the exact quantity of test material has been provided in a container and to weigh it out would cause loss A calculation is made manually as to how much vehicle needs to be added, and this is recorded on Dispense This formulation can then be booked in as a Test Material if subsequent serial dilution is needed.

Unlocking the Box

Unlocking the Box Addition of Analytical Diluent Dispense allows for preparation of a formulation and subsequent sampling , but does not have ability to dilute a sample Here, you can see how we utilise Dispense to record the weight/volume of diluent added to a sample

Unlocking the Box

Unlocking the Box Addition of Analytical Diluent This can be taken further by having multiple dilution steps all the way down to the analytical range

Unlocking the Box Addition of Analytical Diluent This can be taken further by having multiple dilution steps all the way down to the analytical range You can also prepare standards and QC’s using the system

Unlocking the Box- Summary Allows easy access to all formulation & analysis data Fully GLP compliant Can use the system for items it was not designed for Booking in as test material Liquids in capsules Customised labels Inhalation packing / device testing Excipients as test materials or vehicles Use of pre-weighed test material Sample dilution and analytical standards/QC’s Anything else !

Unlocking the Box- Summary We would however like Dispense to be able to do some of these things from within the box ! Ability to Book in as a Test Material with a simple key stroke. Ability to dilute a sample with a simple key stroke

Unlocking the Box – Final Thought